Diabetes control: In a first, US gives nod to ‘artificial pancreas’
The first automated insulin delivery device – dubbed as artificial pancreas – which can monitor blood sugar levels and regularly administer insulin has been approved in the United States of America.
The human pancreas naturally supplies a low, continuous rate of insulin, known as basal or background insulin. In patients with diabetes, the body’s ability to produce or respond to insulin is impaired.
MiniMed 670G hybrid closed looped system, intended to automatically monitor glucose (sugar) and provide appropriate basal insulin doses in people 14 years of age and older with type 1 diabetes, was approved by the US Food and Drug Administration (FDA).
“This first-of-its-kind technology can provide people with type 1 diabetes greater freedom to live their lives without having to consistently and manually monitor baseline glucose levels and administer insulin,” said Jeffrey Shuren, director of the FDA’s Centre for Devices and Radiological Health.
The MiniMed 670G hybrid closed looped system, often referred to as an “artificial pancreas,” is intended to adjust insulin levels with little or no input from the user. It works by measuring glucose levels every five minutes and automatically administering or withholding insulin.
The system includes a sensor that attaches to the body to measure glucose levels under the skin; an insulin pump strapped to the body; and an infusion patch connected to the pump with a catheter that delivers insulin.
While the device automatically adjusts insulin levels, users need to manually request insulin doses to counter carbohydrate (meal) consumption.
Since the pancreas does not make insulin in people with type 1 diabetes, patients have to consistently monitor their glucose levels throughout the day and have insulin therapy through injection with a syringe, an insulin pen or insulin pump to avoid becoming hyperglycemic (high glucose levels).
In addition, management of type 1 diabetes includes following a healthy eating plan and physical activity.
The FDA evaluated data from a clinical trial of the MiniMed 670G hybrid closed looped system that included 123 participants with type 1 diabetes.
The clinical trial included an initial two-week period where the system’s hybrid closed loop was not used followed by a three-month study during which trial participants used the system’s hybrid closed
loop feature as frequently as possible.